The Effects of Compression Stockings on Pressure Parameters in Patients With Chronic Venous Insufficiency

Venous Insufficiency Clinical Trial

— MACIVC  

Official title:

The Effects of Compression Stockings on Pressure Parameters in Patients With Chronic Venous Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01558024
• Other study ID #: AOI/2011/APM-03
• Secondary ID: 2011-A01703-38
• Status: Completed
• Phase: N/A
• First received: March 16, 2012
• Last updated: May 19, 2016
• Start date: July 2014
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial Summary

The main objective of this study is to obtain data to determine, in each individual with and without wearing compression stockings of different strengths and during different postures, the relationship between interface pressure and the area and circumference of the great saphenous vein and posterior tibial veins in the calf and ankle.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The participant must have given his/her informed and signed consent

• The participant must be insured or beneficiary of a health insurance plan

Inclusion criteria for patients in the venous insufficiency group:

• CEAP (Clinical-Etiology-Anatomy-Pathophysiology) Classification : C1S, C3 or C5

Inclusion criteria for healthy volunteers

• general good health

• subgroups including:

• sedentary volunteers (< 2hours of physical activity per week)

• active volunteers (between 2 and 6 hours of physical activity per week)

• athletic volunteers (over 6 hours of physical activity per week for at least 1 year)

Exclusion Criteria:

• The participant is participating in another study, except the "volumetric" counterpart to the present study

• The participant is in an exclusion period determined by a previous study

• The participant is under judicial protection, under tutorship or curatorship

• The participant refuses to sign the consent

• It is impossible to correctly inform the participant

• The participant is pregnant, parturient, or breastfeeding

• Arterial vascular disease, heart, lymph, renal, hepatic, oncologic, metabolic or endocrine or any other condition that may cause or exaggerate edema

Exclusion criteria for healthy volunteers:

• Risk for abnormal bleeding (hemophilia, anticoagulation or antiplatelet)

• Taking diuretics or corticoids

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Venous Insufficiency

Locations

Country	Name	City	State
France	CHU de Montpellier - Hôpital Saint-Eloi	Montpellier
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between D and A/F at the calf	D = the diameters of the largest cross section of the posterior tibial veins at calf level; A = the area of the largest cross section of the posterior tibial veins at the calf level; F = interface pressure measured along the leg using a 13 captor system.	Baseline (Day 0)	No
Secondary	Interface pressure for the leg	Interface pressure (mmHg) measured using 13 captors over the entire leg in the following positions: decubitus dorsal, sitting, orthostatic and orthodynamic.	baseline; day 0	No
Secondary	Calf interstitial pressure	Intramuscular interstitial pressure is measured in the calf for 1/3 or randomly selected participants in the following positions: decubitus dorsal, sitting, orthostatic and orthodynamic.	base line; day 0	No
Secondary	Venous pressure at the ankle (mmHg)	Pressure of the great saphenous vein is measured at the ankle in the following positions: decubitus dorsal, sitting, orthostatic and orthodynamic	baseline; day 0	No
Secondary	Saphenous vein area, calf	Area (mm^2)of the largest cross section of the great saphenous vein at calf level and for the following positions: decubitus dorsal, sitting, orthostatic	baseline, day 0	No
Secondary	Saphenous vein area, ankle	Area (mm^2)of the largest cross section of the great saphenous vein at ankle level and for the following positions: decubitus dorsal, sitting, orthostatic	baseline, day 0	No
Secondary	Posterior tibial vein area, calf	Area (mm^2)of the largest cross section of the posterior tibial veins at calf level and for the following positions: decubitus dorsal, sitting, orthostatic	baseline, day 0	No
Secondary	Posterior tibial vein area, ankle	Area (mm^2)of the largest cross section of the posterior tibial veins at ankle level and for the following positions: decubitus dorsal, sitting, orthostatic	baseline, day 0	No
Secondary	Saphenous vein perimeter, calf	Perimeter (mm)of the largest cross section of the great saphenous vein at calf level and for the following positions: decubitus dorsal, sitting, orthostatic	baseline, day 0	No
Secondary	Saphenous vein perimeter, ankle	Perimeter (mm)of the largest cross section of the great saphenous vein at ankle level and for the following positions: decubitus dorsal, sitting, orthostatic	baseline, day 0	No
Secondary	Posterior tibial vein perimeter, calf	Perimeter (mm)of the largest cross section of the posterior tibial veins at calf level and for the following positions: decubitus dorsal, sitting, orthostatic	baseline, day 0	No
Secondary	Posterior tibial vein perimeter, ankle	Perimeter (mm)of the largest cross section of the posterior tibial veins at ankle level and for the following positions: decubitus dorsal, sitting, orthostatic	baseline, day 0	No
Secondary	Heart height difference (mm); saphenous vein, calf	The difference in height (mm) between the right atrium and the target cross section on the saphenous vein in the following positions: decubitus dorsal, sitting, orthostatic.	baseline, day 0	No
Secondary	Heart height difference (mm); saphenous vein, ankle	The difference in height (mm) between the right atrium and the target cross section on the saphenous vein in the following positions: decubitus dorsal, sitting, orthostatic.	baseline, day 0	No
Secondary	Heart height difference (mm); posterior tibial veins, calf	The difference in height (mm) between the right atrium and the target cross section on the posterior tibial veins in the following positions: decubitus dorsal, sitting, orthostatic.	baseline, day 0	No
Secondary	Heart height difference (mm); posterior tibial vein, ankle	The difference in height (mm) between the right atrium and the target cross section on the posterior tibial veins in the following positions: decubitus dorsal, sitting, orthostatic.	baseline, day 0	No
Secondary	Leg circumference (mm)	The circumference of the leg is measured every 5 cm in a decubitus dorsal position.	baseline; Day 0	No